SOLVE-ACS: Bioresorbable Magnesium-Stents Magmaris in ACS... | NCT03773081

NCT03773081

Protocol Section

Identification Module

Results Section

No data available

No data is available for this block.

Annotation Section

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No data is available for this block.

Document Section

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No data is available for this block.

Derived Section

Miscellaneous Info Module

Status Module

Description Module

Arms/Interventions Module

Arm Groups

Label	Type	Description	Intervention Names
Magmaris implantation	Other	Subjects will undergo a PCI for the implantation of the Magmaris scaffold in accordance with the standard of care and standard hospital practice.	Device: Implantation of the Magmaris scaffold

Interventions

Name	Type	Description	Arm Group Labels	Other Names
Implantation of the Magmaris scaffold	Device	Subjects will undergo a PCI for the implantation of the Magmaris scaffold in accordance with the standard of care and standard hospital practice. Maximum of one single ACS-causing de novo lesions in one separate major epicardial vessels is allowed.

Outcomes Module

Primary Outcomes

Measure	Description	Time Frame
Procedural angiographical success	Procedural angiographical success at the end of PCI, defined as successful Magmaris implantation at the "culprit lesion site" with less than 30% final stenosis (by visual estimation) and distal TIMI 3 flow.	At the end of PCI

Secondary Outcomes

Measure	Description	Time Frame
ST-segment resolution at the electrocardiogram (ECG)	ST-segment resolution at ECG.	Within 60 minutes of primary PCI
Procedural clinical success within hospital stay	No in-hospital clinically-driven target lesion revascularization.

Eligibility Module

Eligibility Criteria

Inclusion Criteria:

Male or female patients of 18 - 70 years of age
STE- or NSTE-ACS with planned invasive therapy strategy
At least coronary one-vessel disease with one angiographically detectable "culprit lesion"
Target lesion length ≤ 21 mm and its diameter is ≥ 2.7mm and ≤ 3.7 mm by QCA or by visual estimation.
Subject is eligible for Dual Anti Platelet Therapy (DAPT) for 12 months after ACS

Additional inclusion criteria MCG-substudy:

Hospitalization for NSTE- ACS in low- and/or risk-class (GRACE-Score ≤ 170) with planned invasive therapy

Exclusion Criteria:

Currently participating within a FIM or RCT and primary endpoint is not reached yet.
Known allergies to: Acetylsalicylic Acid (ASA), clopidogrel, ticlopidine, prasugrel, heparin or any other anticoagulant /antiplatelet required for PCI, contrast medium, sirolimus, or similar drugs or the Magmaris materials including Magnesium, Yttrium, Neodymium, Zirconium, Gadolinium, Dysprosium, Tantalum that cannot be adequately pre-medicated.
Renal insufficiency with serum-creatinine ≥ 2.5 mg/dl or subjects on dialysis.
Known systolic heart failure with left-ventricular ejection fraction (LV-EF≤ 30 %).
Active sepsis.
Presence of cardiogenic shock or heart failure requiring intubation, inotropes, intravenous diuretics or mechanical circulation support.
Refractory ventricular arrhythmia requiring pharmacologic or defibrillator therapy.
Patients under immunosuppressive therapy.
Unprotected significant left main- stenosis.
ACS with culprit lesion in a bypass graft or ACS caused by stent/BVS-thrombosis or stent/BVS-restenosis.
ACS caused by left main coronary artery disease or an ostial target lesion (within 5.0 mm of vessel origin).
Culprit lesion involves a side branch ≥2.0 mm in diameter (bifurcation lesion).
Culprit lesion located within a true vessel bifurcation (including side branch > 2mm) which requires bifurcation-treatment according to the investigator's discretion.
Extent and severity of CAD is such that investigator believes it is likely that bypass surgery will be required within 1 year of enrollment.
Severe calcification or extreme tortuosity of vessel with "culprit lesion".
Culprit lesion with very distal location.
Culprit vessels with "low or no-reflow phenomenon" (TIMI 0,I,II) after mechanical recanalization or pre-dilatation using a non-compliant balloon with 1:1 balloon-to-artery ratio.
Culprit lesions with a length ≥ 21 mm or within vessels with reference diameter≤ 2.7mm or ≥ 3.7 mm by QCA or by visual estimation.
Unsuccessful pre-dilatation, defined as minimal lumen diameter smaller than the respective crossing profile of Magmaris and angiographic complications (e.g. distal embolization, side branch closure, extensive dissections), by visual estimation.

Additional exclusion criteria MCG-substudy:

Non-MCG-safe metal implants
Inability or unwillingness to lie flat for 5 minutes and follow breathing commands

Facility	Status	City	State	ZIP	Country	Contacts
Herz- und Diabeteszentrum NRW		Bad Oeynhausen			Germany
Vivantes Klinikum im Friedrichshain

ID	Term
D054058	Acute Coronary Syndrome
D000072657	ST Elevation Myocardial Infarction
D000072658	Non-ST Elevated Myocardial Infarction

ID	Term
D017202	Myocardial Ischemia
D006331	Heart Diseases
D002318	Cardiovascular Diseases
D014652	Vascular Diseases